POLICY PRIORITIES TO IMPROVE OUR NATION’S HEALTH RESEARCH WITH HUMAN SUBJECTS

ISSUE SUMMARY The design and conduct of ethical research with human subjects is essential to scientific and medical progress to improve the lives and health of all. Recent efforts to update and rethink the regulations concerning federal oversight of human subject research present significant opportunities and challenges, as the relevant agencies have revisited these rules for the first time in 25 years. Proposals to redefine “human subject” and change the nation’s approach to conducting research on biospecimens could dramatically increase institutional burden and stifle research without an appreciable increase in providing individuals with meaningful information or choice about their participation in research.

Issue Background Research with human subjects is an essential driver of scientific In 1979, the National Commission for the Protection of Human progress that improves health and medical care, from interviews Subjects of Biomedical and Behavioral Research released the land- and surveys in the social sciences to clinical trials that evaluate mark Belmont Report, which set forth three basic principles for the safety and efficacy of drugs and devices. The cornerstone research with human subjects: respect for persons, beneficence, of this research is its ethical conduct, which requires not only and justice. Respect for persons is the obligation for researchers to that the research itself is ethical, but that its conduct reflects treat individuals as autonomous agents capable of self-determi- a respect for the individual participants in that research. nation and to protect those lacking this capacity; the principle The regulatory framework for the oversight of research with of beneficence is the duty to minimize harm and maximize human subjects, known as the “Common Rule,” is based benefits, both at the individual and societal levels; and justice on sound ethical principles but was last updated 25 years ago. refers to the fair distribution of the benefits and burdens of the The design and conduct of research has changed in the ensuing research process, considering the question of who ought to enjoy years, in the settings where research occurs; the volume of data the benefits of research and who ought to bear its burdens. collected, used, and shared; the technology employed; and the level of public engagement in and understanding of research. With its ethical foundation firmly rooted in the principles of The Department of Health and Human Services (HHS) the Belmont Report, the Common Rule provides the regulatory published a Notice of Proposed Rulemaking to revise the requirements for research involving human subjects that is funded Common Rule in September 2015, and the AAMC, along with or overseen by the 15 federal agencies that concurrently adopted numerous other stakeholders, provided extensive comments it, from the National Aeronautics and Space Administration to on the proposed approach. the Environmental Protection Agency. Research subject to the Common Rule must undergo ethical review by an Institutional Review Board (IRB).

In 2011, the Office of the Secretary of Health and Human Services, with the Office of Science and Technology Policy in the Executive Office of the President, began the process of revising the rule. The revision process stems from broad consensus that the decades-old regulations were not adequate for the interconnected and advanced research landscape of today. Due to advances such as genetic sequencing, bioinformatics, and “big data” analysis, the capacity to conduct new types of research has been greatly expanded, and the dividing line between research and care delivery in a learning health care system is less clear.

Association of 19 | PART 2: MEDICAL RESEARCH AND INNOVATION American Medical Colleges POLICY PRIORITIES TO IMPROVE OUR NATION’S HEALTH RESEARCH WITH HUMAN SUBJECTS

Since July 2011, when an Advance Notice of Proposed Rulemaking • The AAMC disagrees with proposals to define research with (ANPRM) was published indicating HHS’s intention to revise de-identified biospecimens as human subject research and the Common Rule, the broad research community has been to require all individuals whose biospecimens might be used actively engaged in this process. There were over 1,000 public in future research to sign a generic “broad consent” document. comments to the ANPRM, and after the subsequent September Instead, the AAMC proposes the creation of a “robust notifi- 2015 Notice of Proposed Rulemaking (NPRM), HHS received cation” requirement, which would require institutions to give over 2,000 comments, many critical of the proposed approach. individuals access to important information about how their biospecimens might facilitate research to advance medical Concerns about the proposed revisions to the Common Rule knowledge and treatment. focused on the change to the definition of “human subject” to include biospecimens (biological materials taken from the • As described in its January 2016 comments on the proposed body such as blood or tissue), even those without any associated changes to the Common Rule, the AAMC continues to urge data about the individual from whom those specimens were HHS to substantially revise the proposal and take advantage obtained. This represents a fundamental shift in how research of the “unique opportunity to reframe and modernize the with unidentified biospecimens is now conducted and would Common Rule and to capture the promise and potential potentially increase the complexity and cost of this critical of research breakthroughs while recognizing that individuals research significantly without a commensurate benefit for want to understand the commitments and contributions they or increased information to individuals. are making to move science and health forward.”

On June 29, 2016, the National Academies of Sciences, Engineer- Related Issue ing, and Medicine (National Academies) released the second part • Research Regulatory Burden of a report titled Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. In AAMC Contacts this congressionally requested report, the National Academies recommended the immediate withdrawal of the proposed rule Tannaz Rasouli and the creation of a new national commission to recommend Senior Director, Public Policy and Strategic Outreach to the president, Congress, and the federal agencies “how the 202-828-0057 basic ethical principles governing human subjects research should [email protected] be applied to unresolved human research questions and novel Heather H. Pierce, JD, MPH human research contexts.” Senior Director, Science Policy 202-478-9926 AAMC Policy Recommendations [email protected] • The AAMC and its members are wholly committed to ensuring that research with human subjects is designed and conducted Web Resources in an ethical manner with appropriate institutional and federal AAMC Resources on the Common Rule oversight and agrees that the regulatory framework for this www.aamc.org/commonrule oversight should be firmly grounded in sound ethical principles. The Office for Human Research Protections www.hhs.gov/ohrp

Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century www.nap.edu/catalog/21824/optimizing-the-nations- investment-in-academic-research-a-new-regulatory

Association of 20 | PART 2: MEDICAL RESEARCH AND INNOVATION American Medical Colleges